OECD Unique Identifier details

4Ø-3-2

Commodity:

Soyabean / Soybeans

Traits:

Glyphosate tolerance

Russian Federation

Name of product applicant:

Monsanto Company

Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences; (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM soybean line 40-3-2 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.

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Date of authorization:

22/09/1999

Scope of authorization:

Food

Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):

Summary of the safety assessment (food safety):

The result of the complex safety assessment of glyphosate-tolerant transgenic
soybean line 40-3-2 is the established absence of any toxic, genotoxic,
immune system modulating, or allergenic effects as indicated by all examined
parameters. Analysis of chemical composition of transgenic soybean
line 40-3-2 and the protein concentrate derived from it, showed its identity
to the composition of their conventional counterparts. Based on the
results of the studies, the State Sanitation Service of the Russian Federation (Department of State Sanitation and Epidemiological Inspectorate) granted
the Registration Certificate, which allows use of the transgenic soybean line
40-3-2 in the food industry and allows it to be placed on the market without
restrictions.
More information is on P. 44-69 of Monograph ”Genetically Modified Food Sources. Safety Assessment and Control”, published by Elsevier Inc. Academic Press in 2013 (uploaded file)

The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.